SPL v2
SPL
SPL Set ID 58e1757c-45ce-455e-bd64-a9e99cd3680f
Route
TOPICAL
Published
Effective Date 2023-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Glycerin Polyethylene Glycol 300 Polyethylene Glycol 1500 Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-30

Description

DRUG FACTS

Purpose

Antiseptic-germicidal


Medication Information

Purpose

Antiseptic-germicidal

Description

DRUG FACTS

Uses

for the treatment of:

  • minor wounds
  • infections
  • kills bacteria promptly
Section 42229-5

DRUG FACTS

Warnings

For external use only.

Directions
  • apply directly to affected area
  • may be bandaged
Do Not Use
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Questions?

call (386) 414- 1809

Distributed by Dr Radow's PO Box 952 Deland FL, 32721-0952  

Active Ingredient

Povidone Iodine USP10% w/w (available iodine 1%)

Other Information
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.
  • For control no. and expiration date, see carton and/or crimp of tube.
  • Will not stain natural fabrics.
  • Protect from freezing.
Inactive Ingredients

glycerin, PEG-6, PEG-32, propylene glycol

When Using This Product
  • Avoid contact with eyes.
Stop Use and Ask A Doctor If
  • redness, irritation or swelling occurs or pain persists
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel – 1 Oz. Tube

Doctor Radow                  NDC 81584-1102-1

POVIDINE – IODINE 10%

First Aid Antiseptic Ointment

AVAILABLE IODINE 1% 

NET WT. 1 OZ (28.35 g)

Principal Display Panel – 1 Oz. Carton

Doctor Radow                     NDC 81584-1102-1

Povidone Iodine 10%

First Aid Antiseptic Ointment

Available Iodine 1%

NET WT 1 OZ (28.35g)

Keep This and All Drugs Out of the Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Structured Label Content

Uses

for the treatment of:

  • minor wounds
  • infections
  • kills bacteria promptly
Section 42229-5 (42229-5)

DRUG FACTS

Purpose

Antiseptic-germicidal

Warnings

For external use only.

Directions
  • apply directly to affected area
  • may be bandaged
Do Not Use (Do not use)
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Questions?

call (386) 414- 1809

Distributed by Dr Radow's PO Box 952 Deland FL, 32721-0952  

Active Ingredient (Active ingredient)

Povidone Iodine USP10% w/w (available iodine 1%)

Other Information (Other information)
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.
  • For control no. and expiration date, see carton and/or crimp of tube.
  • Will not stain natural fabrics.
  • Protect from freezing.
Inactive Ingredients (Inactive ingredients)

glycerin, PEG-6, PEG-32, propylene glycol

When Using This Product (When using this product)
  • Avoid contact with eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • redness, irritation or swelling occurs or pain persists
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel – 1 Oz. Tube (Principal Display Panel – 1 oz. Tube)

Doctor Radow                  NDC 81584-1102-1

POVIDINE – IODINE 10%

First Aid Antiseptic Ointment

AVAILABLE IODINE 1% 

NET WT. 1 OZ (28.35 g)

Principal Display Panel – 1 Oz. Carton (Principal Display Panel – 1 oz. Carton)

Doctor Radow                     NDC 81584-1102-1

Povidone Iodine 10%

First Aid Antiseptic Ointment

Available Iodine 1%

NET WT 1 OZ (28.35g)

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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